Fractional Exhaled NO, Extended NO Analysis and NO/CO Diffusing Capacity in Patients Receiving Thoracic Radiation Therapy: a Single Centre Study

University of Zurich1 site in 1 country3 target enrollmentFebruary 15, 2018

ConditionsRadiotherapy

Overview

Phase: Not Applicable
Intervention: Not specified
Conditions: Radiotherapy
Sponsor: University of Zurich
Enrollment: 3
Locations: 1
Primary Endpoint: Change in diffusing capacity for nitric oxide (DLNO)
Status: Terminated
Last Updated: 5 years ago

Overview Investigators Eligibility Criteria Outcomes Sites Similar Trials

Overview

Brief Summary

The investigators aim to investigate the impact of thoracic radiation therapy on diffusion capacity of the lung (primary endpoint: diffusion capacity for nitric oxide, DLNO) and on exhaled nitric oxide.

Registry

clinicaltrials.gov

Start Date

February 15, 2018

End Date

April 1, 2021

Last Updated

5 years ago

Study Type

Observational

Sex

All

Investigators

Sponsor

University of Zurich

Responsible Party

Sponsor

Eligibility Criteria

Inclusion Criteria

•planned but not already commenced radiation therapy (RT) of the chest, with or without pre-RT surgery.
•signed informed consent of the participant

Exclusion Criteria

•thoracic RT in the past
•treatment with immune checkpoint inhibitors
•unstable condition affecting participation in the measurements

Outcomes

Primary Outcomes

Change in diffusing capacity for nitric oxide (DLNO)

Time Frame: Before start of radiation therapy (RT), at the day of end of RT, 6 weeks and 12 months after end of RT

Secondary Outcomes

Transfer Coefficient for nitric oxide (DLNO/VA)(Before start of radiation therapy (RT), at the day of end of RT, 6 weeks and 12 months after end of RT)
Alveolar Volume (VA)(Before start of radiation therapy (RT), at the day of end of RT, 6 weeks and 12 months after end of RT)
Pulmonary capillary blood volume (Vc)(Before start of radiation therapy (RT), at the day of end of RT, 6 weeks and 12 months after end of RT)
Forced expiratory flow between 25% and 75% of forced vital capacity(Before start of radiation therapy (RT), at the day of end of RT, 6 weeks and 12 months after end of RT)
Transfer Coefficient for carbon monoxide (DLCO/VA)(Before start of radiation therapy (RT), at the day of end of RT, 6 weeks and 12 months after end of RT)
Ratio of DLNO and DLCO(Before start of radiation therapy (RT), at the day of end of RT, 6 weeks and 12 months after end of RT)
Alveolar-capillary membrane-diffusing capacity for carbon monoxide (DMCO)(Before start of radiation therapy (RT), at the day of end of RT, 6 weeks and 12 months after end of RT)
Concentration of nitric oxide in the gas phase of the alveolar or acinar region (CANO)(Before start of radiation therapy (RT), at the day of end of RT, 6 weeks and 12 months after end of RT)
Tissue concentration of nitric oxide of the airway wall (CawNO)(Before start of radiation therapy (RT), at the day of end of RT, 6 weeks and 12 months after end of RT)
Forced expiratory volume in 1 second(Before start of radiation therapy (RT), at the day of end of RT, 6 weeks and 12 months after end of RT)
Diffusing capacity for carbon monoxide (DLCO)(Before start of radiation therapy (RT), at the day of end of RT, 6 weeks and 12 months after end of RT)
Airway compartment diffusing capacity of nitric oxide from the of of the airway wall to the gas stream (DawNO)(Before start of radiation therapy (RT), at the day of end of RT, 6 weeks and 12 months after end of RT)
Total flux of nitric oxide in the conducting airway compartment (JawNO)(Before start of radiation therapy (RT), at the day of end of RT, 6 weeks and 12 months after end of RT)
Fractional concentration of exhaled nitric oxide at a flow rate of 50mL/s (FENO50)(Before start of radiation therapy (RT), at the day of end of RT, 6 weeks and 12 months after end of RT)
Forced vital capacity(Before start of radiation therapy (RT), at the day of end of RT, 6 weeks and 12 months after end of RT)